The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.

The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up.

The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up.

Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for subjects in both the MRI and Control groups.

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

ImageReady(TM) MR Conditional Pacing System Clinical Study

Official Title ICMJE

ImageReady(TM) MR Conditional Pacing System Clinical Study

Brief Summary

The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide

The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

Other Names:

MRI

MR Scan

Device: ImageReady System implant

Pacemaker and lead(s) implant

Other Names:

Single chamber pacemaker implant

Dual chamber pacemaker implant

Pace/ Sense pacemaker lead implant

Study Arm (s)

Experimental: MRI Group

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

Interventions:

Radiation: MRI

Device: ImageReady System implant

Experimental: Control Group

Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.

Intervention: Device: ImageReady System implant

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Active, not recruiting

Estimated Enrollment ICMJE

363

Estimated Completion Date

February 2019

Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Subject must have the ImageReady System as their initial (de novo) pacing system implant

Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography

Subject is able and willing to undergo an MRI scan without intravenous sedation

Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol

Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

Subject has or has had any pacing or ICD system implants

Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant

Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol

Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study

Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)

Subject has a mechanical tricuspid heart valve

Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries* that are not in conflict and do not affect the following:

Schedule of procedures for the SAMURAI Study (i.e. should not cause additional or missed visits);